On 22 June 2012, Theratechnologies, the Canadian-based company responsible for developing tesamorelin, a growth hormone releasing factor (GHRF) that reduces central visceral fat, released a press release relating to regulatory issues.1
Foremost of these was the announcement that filing for approval in the EU has been withdrawn, meaning that although approved in the U.S., European patients will not be able to access this option in the near future.
The brief detail cited lack of safety data (>48 weeks) concerning the increased levels of insulin-like growth factor (IGF-1) and the lack of cardiovascular endpoint to evaluate the risk/benefit ratio.
Community commentary of the company studies have also highlighted the inadequacy of the trial design for regulatory studies, which involved discontinuing treatment in all patients at the end of the study. This resulted in the unethical issue of withdrawing successful treatment from responders, but also ensuring that no longer term safety or management data continue to accrue during follow-up, while regulatory submissions were ongoing.2
The press release also referred to further data required on long-term safety by the Canadian regulatory agency, that the company needs to answer within 90 days and a manufacturing deficiency relating to the regulatory decision in Brazil
The FDA approved tesamorelin in the U.S. in November 2010.
While tesamorelin is far from an ideal treatment, and may only be suitable for a minority of patients with lipohypertrophy, in the absence of effective treatment, it is disappointing that European patients with be further denied access, especially as European patients participated in the research.
However, it also raises the issue of disparity of approaches by the U.S. and European regulatory agencies.
The FDA have approved a range of treatment to mediate metabolic complications, none of which have received EU licenses, even within a limited and narrow indication.
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